Catalog Number

-

Brand Name

Spectre

Version/Model Number

98/9900

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K092713

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Public Device Record Key

feed2351-372b-44e1-9820-6fa7393171cb

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-